KS P ISO 8638-2012 Cardiovascular implants and extracorporeal systems －Extracorporeal blood circuit for haemodialysers haemodiafilters and haemofilters《血液透析器、血液过滤器和血液浓缩器的体外血液回路》.pdf

1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 8638 , KS P ISO 8638:2012 2012 12 27 http:/www.kats.go.krKS P ISO 8638:2012 : ( ) ( ) () ( ) : (http:/www.standard.go.kr) ： ：2002 6 29 ：2012 12 27 2012-0767 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 8638:2012 i ii . iii 1 1 2 1 3

2、 .2 4 2 4.1 .2 4.2 .3 4.3 .3 4.4 3 4.5 5 4.6 5 5 5 5.1 .5 5.2 .6 5.3 .6 5.4 .6 5.5 6 5.6 10 5.7 10 6 10 6.1 10 6.2 .10 6.3 .11 6.4 .11 13 KS P ISO 8638:2012 ii . KS P ISO 8638： 2007 . . , , . , , . KS P ISO 8638:2012 iii 2010 3 ISO 8638, Cardiovascular implants and extracorporeal systems Extracorpor

3、eal blood circuit for haemodialysers, haemodiafilters and haemofilters , . KS P ISO 8638:2012 , Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters 1 , , ( , “ ” .) ( ) (transducer) . . , , , , , , , , KS P ISO 8637 . 2

4、 . . ( ) . KS P ISO 10993 1, 1： KS P ISO 10993 4, 4： KS P ISO 10993 7, 7： KS P ISO 10993 11, 11： ISO 594 2, Conical fittings with 6 %(Luer) taper for syringes, needles and certain other medical equipment Part 2： Lock fitting ISO 7864, Sterile hypodermic needles for single use KS P ISO 8638:2012 2 3

5、. 3.1 (air-capture chamber) , . 3.2 (extracorporeal blood circuit) , ： (air-capture chambers), (transducer protector) 3.3 (fluid pathway) 3.4 (labelling) , , , , , , 3.5 (pump segment) 3.6 (transducer protector) (pressure-transmitting sterile barrier) (3.2) 4 4.1 5.2 . , , KS P ISO 8638:2012 3 . 4.2

6、 . 5.3 . 4.3 . 5.4 . 4.4 4.4.1 5.5.1 , 1.5 700 mmHg( 93.3 kPa) , . 4.4.2 , , 4.4.2.1 , , 1 . 5.5.2 . 4.4.2.2 ISO 594 2 . ： mm 1 , , KS P ISO 8638:2012 4 4.4.3 , ISO 594 2 6 %(Luer) . 5.5.3 . 4.4.4 , , ISO 594 2 taper lock fitting . 5.5.4 . 4.4.5 , . 100 mm . 5.5.5 . 4.4.6 4.4.6.1 5.5.6.1 . . 4.4.6.2

7、 5.5.6.2 . 4.4.7 . 5.5.7 . (priming volume) . 4.4.8 . 5.5.8 . 4.4.9 4.4.9.1 . 1.5 . ( ) . 5.5.9 KS P ISO 8638:2012 5 . 4.4.9.2 , . 1.5 . ( ) . 5.5.9 . 4.4.10 . 5.5.10 . 4.4.11 ( 0 mmHg 250 mmHg) . 5.5.11 . 4.5 , . . 5.6 . 4.6 . 5.7 . 5 5.1 4. , . , . , . (371) . , . . , . . (head) ; ; ; pH; , , KS P

8、 ISO 8638:2012 6 ; ; (trap); , , , . 5.2 , , . KS P ISO 10993 1, KS P ISO 10993 4, KS P ISO 10993 7 . 5.3 4.2 . 5.4 4.3 KS P ISO 10993 11 . 5.5 5.5.1 5.5.1.1 4.4.1( ) . a) (371) . . 1.5 . 10 . b) . (371) . 1.5 . 10 . 5.5.1.2 4.4.1( ) . a) . (371) . 700 mmHg( 93.3 kPa ), . 10 . b) (371) . . 1.5 700 m

9、mHg( 93.3 kPa ), . 10 . 5.5.2 , KS P ISO 8638:2012 7 4.4.2 ( 1, 2, 3 ). ： mm 1 2 2 6 % KS P ISO 8638:2012 8 ： mm 3 ISO 5.5.3 4.4.3 (ISO 594 2 ). 5.5.4 4.4.4 (ISO 594 2 ). 5.5.5 4.4.5 . 5.5.6 KS P ISO 8638:2012 9 5.5.6.1 4.4.6.1 . (371) 1.5 6.4(f)(1) . , 0.8 mm(21 ) ISO 7864 . . 6 , . , (371) . (371)

10、 . 700 mmHg 1.5 . , 70 mmHg . . 10 10 . 6 , . . 5.5.6.2 4.4.6.2 . (371) 1.5 6.4(f)(1) . . 10 10 . 6 , . , (371) . (371) . 700 mmHg 1.5 . , 700 mmHg . . 10 10 . 6 , . 5.5.7 4.4.7 . - . 5.5.8 - 4.4.8 . 5.5.9 4.4.9.1 4.4.9.2 1.5 . , , 1.5 , 1 , . , KS P ISO 8638:2012 10 (Luer) . 4.4.4 . . 5.5.10 4.4.10

11、 . 5.5.11 4.4.11 0 mmHg 250 mmHg . - . 6.4 f) 3) . 5.6 4.5 , . 5.7 4.6 , . 1.5 20 . . 6 6.1 . a) b) - , KS S ISO 7000 KS P ISO 15223 . 6.2 . a) b) c) d) e) , f) / / g) KS P ISO 8638:2012 11 h) “ ” i) j) , “ , ” k) , KS S ISO 7000 KS P ISO 15223 . 6.3 . a) b) 6.3 a) , c) , d) e) f) g) / / h) , KS S I

12、SO 7000 KS P ISO 15223 . 6.4 . a) b) c) d) e) f) , , 1) ( ) 2) 3) , 4) 5) 6) 7) g) h) i) , . j) KS P ISO 8638:2012 12 k) l) m) , n) ( , ) o) , p) q) r) s) t) (pathway) , KS S ISO 7000 KS P ISO 15223 . KS P ISO 8638:2012 13 1 KS S ISO 7000, 2 KS P ISO 8637, , , , 3 ISO 11135 1, Sterilization of healt

13、h care products Ethylene oxide Part 1： Requirements for development, validation and routine control of a sterilization process for medical devices 4 ISO 11135 2, Sterilization of health care products Ethylene oxide Part 2： Guidance on the application of ISO 11135 1 5 KS P ISO 11137 1, 1： , 6 KS P IS

14、O 11137 2, 2： 7 KS P ISO 11137 3, 3： 8 KS P ISO 14937, , , 9 ISO 15223 1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1： General requirements 10 ISO 15223 2, Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2： Symbol development, selection and validation 11 KS P ISO 17665 1, 1： , 12 ISO 17665 2, Sterilization of health care products Moist heat Part 2 ： Guidance on the application of ISO 17665 1 , 153787 1 145 3(16) (02)26240114 (02)26240148 http:/www